Device recall
Z-0595-2018: Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The…
FDA device recall · Class II · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-0595-2018 |
|---|---|
| Recall event | 79007 |
| Product | Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test… |
| Product code | NSU |
| Recalling firm | Hologic, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2022 |
| 510(k) numbers | K132251 |
| FEI number | 2024800 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database